Senior Scientist - HPLC UPLC KF and cGMP

Pharmaceutical Product Development (PPD)

NJ-Summit-FSP Summit NJ


PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!  

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

As a Senior Scientist you will perform complex laboratory analysis of pharmaceutical products and proficiently use analytical instrumentation, calculate and analyze data and record data in adherence with PPD SOP's and the industry.

In this position youwill develop, validate, and implement analytical methods to assess physicaland chemical properties of pharmaceutical materials. This work is conducted in a highly collaborative,multi-disciplinary team charged with the overall research & development of our activeingredients, formulated products, and the associated manufacturing processes. You will playan important but supporting role throughout the development of new drugcandidates from discovery to commercialization, contributing to the advancement of newtherapeutics.

DUTIES AND RESPONSIBILITIES

Contributes to the development of priority drug candidates through the development, validation,and implementation of analytical methods involving modern analytical instrumentation including HPLC/UPLC, GC, dissolution, FT-IR, Karl Fischer titrations, etc.Transfers validated methods to customer labs, including Client and partner-owned qualitycontrol (QC) labs.Performs testing for development and clinical materials and stability samples in accordancewith established methods, specifications and protocols under supervision.Knows the fundamentals of analytical methodology and can troubleshoot instrumentation andmethod performance issues of routine complexity.Documents / reviews laboratory work using laboratory notebooks / worksheets that is detailed,timely and in compliance with GLP / GMP requirements.Contributes data to the preparation of high-quality technical reports as source documents forregulatory submissions.Reviews data for compliance and adherence to specifications and acceptance criteria.Communicates results according to project timelines and works with collaborators tounderstand project needs and contribute to overall analytical control strategy. Draws basicconclusions from data and results.Complies with Environmental Health and Safety RequirementsOther duties as assigned by supervisor.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.  

PPD Defining Principles: 

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD - 

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you

PPDFSP

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!  

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

As a Senior Scientist you will perform complex laboratory analysis of pharmaceutical products and proficiently use analytical instrumentation, calculate and analyze data and record data in adherence with PPD SOP's and the industry.

In this position youwill develop, validate, and implement analytical methods to assess physicaland chemical properties of pharmaceutical materials. This work is conducted in a highly collaborative,multi-disciplinary team charged with the overall research & development of our activeingredients, formulated products, and the associated manufacturing processes. You will playan important but supporting role throughout the development of new drugcandidates from discovery to commercialization, contributing to the advancement of newtherapeutics.

DUTIES AND RESPONSIBILITIES

Contributes to the development of priority drug candidates through the development, validation,and implementation of analytical methods involving modern analytical instrumentation including HPLC/UPLC, GC, dissolution, FT-IR, Karl Fischer titrations, etc.Transfers validated methods to customer labs, including Client and partner-owned qualitycontrol (QC) labs.Performs testing for development and clinical materials and stability samples in accordancewith established methods, specifications and protocols under supervision.Knows the fundamentals of analytical methodology and can troubleshoot instrumentation andmethod performance issues of routine complexity.Documents / reviews laboratory work using laboratory notebooks / worksheets that is detailed,timely and in compliance with GLP / GMP requirements.Contributes data to the preparation of high-quality technical reports as source documents forregulatory submissions.Reviews data for compliance and adherence to specifications and acceptance criteria.Communicates results according to project timelines and works with collaborators tounderstand project needs and contribute to overall analytical control strategy. Draws basicconclusions from data and results.Complies with Environmental Health and Safety RequirementsOther duties as assigned by supervisor.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.  

PPD Defining Principles: 

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD - 

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you

PPDFSP

Education and Experience:  

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:  

Solid understanding and knowledge of general chemistry and separation science At least 2 years of experience in a regulated GMP lab.Hands-on experience with separations techniques (HPLC, UPLC, GC, etc.)Familiar with HPLC, dissolution, FT-IR, UV/VIS spectrophotometry, titrations, etc.Experience in laboratory investigation and documentation of Out-of-Specification results.Experience in the development and performance of analytical tests for a variety of drugsubstances and products (including solid oral dosage forms and injectables) is a plus.Familiar writing technical reportsFull understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance Ability to utilize Microsoft Excel and Word to perform tasks Proficiency on technical operating systems Proven problem solving and troubleshooting abilities Effective oral and written communication skills Proven ability in technical writing skills Time management and project management skills Ability to work in a collaborative work environment with a team Proven problem solving and troubleshooting abilities Ability to train junior staff Working Environment:  

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role: 

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. 

Able to work upright and stationary and/or standing for typical working hours.  

Able to lift and move objects up to 25 pounds  

Able to work in non-traditional work environments.  

Able to use and learn standard office equipment and technology with proficiency.  

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. 

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. 

Education and Experience:  

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:  

Solid understanding and knowledge of general chemistry and separation science At least 2 years of experience in a regulated GMP lab.Hands-on experience with separations techniques (HPLC, UPLC, GC, etc.)Familiar with HPLC, dissolution, FT-IR, UV/VIS spectrophotometry, titrations, etc.Experience in laboratory investigation and documentation of Out-of-Specification results.Experience in the development and performance of analytical tests for a variety of drugsubstances and products (including solid oral dosage forms and injectables) is a plus.Familiar writing technical reportsFull understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance Ability to utilize Microsoft Excel and Word to perform tasks Proficiency on technical operating systems Proven problem solving and troubleshooting abilities Effective oral and written communication skills Proven ability in technical writing skills Time management and project management skills Ability to work in a collaborative work environment with a team Proven problem solving and troubleshooting abilities Ability to train junior staff Working Environment:  

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role: 

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. 

Able to work upright and stationary and/or standing for typical working hours.  

Able to lift and move objects up to 25 pounds  

Able to work in non-traditional work environments.  

Able to use and learn standard office equipment and technology with proficiency.  

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. 

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. 


2020-07-14 00:00:00


Apply to this job